2026 has already marked a transformative period for liver transplantation and organ preservation. Earlier this year, the U.S. Food and Drug Administration granted De Novo clearance to the VitaSmart™ Hypothermic Oxygenated Perfusion (HOPE) System, the first FDA-cleared hypothermic oxygenated perfusion system for liver transplantation in the United States.
Let’s take a look at the significance of this FDA clearance and the impact the VitaSmart™ Hypothermic Oxygenated Perfusion (HOPE) System is already having on the transplantation community – and, most importantly, the transplant patients they serve.
New Financing of $110 Million Demonstrates Investor Confidence in VitaSmart™ and HOPE Innovative Technology and Potential for Standard of Care in Liver Transplantation
Bridge to Life is excited to share news of the successful completion of a $110 million Series C and debt financing. Proceeds will fuel the VitaSmart™ launch by expanding the field team and providing the working capital to reach every U.S. transplant center. This funding will also be used to advance Bridge to Life’s new product pipeline, including a proprietary viability assessment tool designed to raise industry standards with a validated biomarker that provides transplant centers with the data to save more organs and lives, as well as multi-organ product research and development.
This financing marks an important milestone for Bridge to Life and reflects the confidence our investors have in our technology, team, and long-term growth strategy. The VitaSmart™ launch has outpaced our expectations, as leading academic centers are adopting it rapidly. This financing enables us to meet that demand while advancing a pipeline that expands beyond liver transplantation to other solid organ transplants.
Rapid Adoption of the VitaSmart™ Hypothermic Oxygenated Machine Perfusion (HOPE) System
Transplant surgeons are already impressed by the cleared labeling, which supports broad clinical application, including both Donation after Circulatory Death (DCD) and Donation after Brain Death (DBD) donor livers. This milestone represents more than the introduction of a new technology platform. It reflects the broader shift within transplantation toward biologically guided organ preservation strategies focused on mitochondrial protection, improved graft utilization, and expanded access to transplantation.
Within the scope of its cleared indication, VitaSmart™ is designed to support:
- Improved organ utilization
- Simplified workflow integration
- Reduced operational complexity
- A scalable and capital-efficient approach to advanced organ preservation
These considerations are increasingly important as transplant centers navigate rising clinical demand, operational constraints, and the ongoing need to safely expand donor organ utilization.
Following FDA clearance, Bridge to Life has begun supporting the implementation of HOPE programs across leading U.S. transplant centers. Duke University Hospital became one of the first major centers in the country to clinically implement the VitaSmart™ System, successfully preserving and transplanting a DCD donor liver using HOPE. Additional centers, including the University of Rochester Medical Center and Methodist Dallas, have also initiated clinical HOPE programs, with further installations continuing across the United States.
Unlike static cold storage alone, HOPE delivers controlled oxygenation under hypothermic conditions to support mitochondrial recovery and reduce the risk of ischemia-reperfusion injury during transplantation. As clinical experience continues to grow globally, transplant centers are increasingly evaluating how advanced preservation strategies may improve utilization of higher-risk donor organs while supporting post-transplant outcomes and operational efficiency.
Landmark HOPE Trial Published in JAMA Surgery
Another major milestone for the field was reached with the publication of the Bridge to HOPE pivotal clinical trial in JAMA Surgery. The study, “Portal-Venous Hypothermic Oxygenated Perfusion for Liver Transplantation: The Bridge to HOPE Trial,” represents the first multicenter randomized U.S. trial evaluating end-ischemic portal-venous HOPE in higher-risk donor livers, including both DCD and DBD grafts. Conducted across 15 U.S. transplant centers and enrolling 219 recipients, the study contributes to the growing body of evidence supporting hypothermic oxygenated perfusion as a clinically meaningful preservation strategy in liver transplantation.
The authors set out to answer the question: Does back-to-base portal-venous hypothermic oxygenated perfusion (HOPE) improve recipient outcomes compared with static cold storage alone?
Their findings and conclusion were that HOPE resulted in reduced early allograft dysfunction compared with static cold storage alone; additionally, HOPE was associated with lower model for early allograft function score and shorter hospital stays. The HOPE approach was safe and associated with reduced EAD, MEAF score, and LOS. These findings support the use of HOPE as a pragmatic strategy to improve early posttransplant outcomes.
Real-World Experience Shows that VitaSmart™ is Preserving Organs More Effectively – and Improving Patients’ Lives!
Birmingham Children’s Hospital
Birmingham Children’s Hospital, Birmingham, UK has been so impressed with its results using the VitaSmart™ Hypothermic Oxygenated Machine Perfusion System that it requested support to produce a video showcasing two families’ heartwarming stories. This is exactly why we at Bridge to Life do what we do. See this incredibly moving video here.
Methodist Dallas Medical Center
The impact of HOPE is already becoming evident at transplant centers implementing the technology. In June, Methodist Dallas Medical Center shared the story of Linda Williams, a 72-year-old liver transplant recipient who became the first patient at the center to receive a donor liver preserved using the VitaSmart™ Hypothermic Oxygenated Perfusion (HOPE) System. Following years of declining health while awaiting transplantation, Linda successfully received her transplant in March and has since returned to many of the activities she enjoys with her family.
While scientific evidence, regulatory milestones, and clinical adoption remain critical drivers of progress, stories like Linda’s remind us of the ultimate purpose behind these advances. The ultimate goal of every advancement in organ preservation is to help more patients gain access to life-saving transplantation and improved quality of life. You can read Linda’s story here: Pump gives liver recipient the HOPE she needed.
Life Connections of Ohio
Innovation surrounding HOPE is also expanding beyond transplant centers themselves. Recently, Life Connection of Ohio became the first organ procurement organization (OPO) in the United States to utilize the VitaSmart™ Hypothermic Oxygenated Perfusion (HOPE) System as part of its organ preservation process. According to the organization, HOPE perfusion helped facilitate the successful transplantation of a donor liver that was initially not considered suitable for transplant. See the LinkedIn Post here.
This milestone highlights the growing role advanced preservation technologies may play across the broader donation and transplantation ecosystem.
U.K. NHS Oxford Health Conducts World’s First Pancreas Transplant to Initiate a Study Using Hypothermic Oxygenated Machine Perfusion
A clinical study at the University of Oxford has recruited its first participant, marking the world’s first successful transplantation of a perfused human pancreas and a major advance in efforts to improve organ preservation for transplantation.
The pancreas is one of the most challenging organs to preserve. It is particularly vulnerable to damage during the period between donation and transplantation, and the current standard method – static cold storage – slows deterioration but cannot prevent it. Improving preservation is therefore critical to increasing the number of pancreases suitable for transplant and reducing post-transplant complications.
Hypothermic Oxygenated machine perfusion is an emerging technology that may better protect the pancreas during storage by supplying oxygen and removing harmful metabolites. This approach has the potential to improve organ quality and transplant outcomes.
The Hypothermic Oxygenated Pancreas Perfusion (HOPP) study will recruit 30 patients from the simultaneous kidney–pancreas transplant waiting list at Oxford University Hospitals NHS Foundation Trust. The study is evaluating a novel preservation technique that circulates oxygenated cold fluid through donor pancreases, replacing the traditional method of static cold storage on ice. Pancreas transplantation – often performed alongside kidney transplantation for people with severe diabetes – can restore normal blood glucose control and remove the need for insulin therapy. However, limitations of current preservation methods mean that up to half of donated pancreases are ultimately not used for transplantation.
Building on advances in kidney and liver transplantation, the HOPP study will perfuse each donor pancreas for two hours while the recipient’s kidney transplant is underway, before transplanting the pancreas using standard surgical techniques. Outcomes will be compared with those of 60 recent patients whose organs were preserved using conventional cold storage. Researchers will assess pancreas and kidney function, complications, surgical requirements, and length of hospital stay.
A dedicated Patient and Public Involvement (PPI) group has played a central role in shaping the study design and will continue to support oversight and dissemination throughout the project. This research could reduce organ injury and increase the number of pancreases safely used for transplant.
The study is led by Professor James Hunter, Chief Investigator and Associate Professor at the University of Oxford’s Nuffield Department of Surgical Sciences, with day-to-day delivery overseen by Dr Mohamed Elzawahry, post-doctoral academic clinician.
Professor James Hunter said:
“It is an exciting time to be part of this research project, and although it is early days, having such a positive outcome for the first patient is very promising. Without the generosity of families who support donation, this study would not be possible, and lifesaving transplants would not happen.”
Dr Mohamed Elzawahry added:
“Successfully recruiting our first participant marks a significant achievement in the challenging field of pancreas preservation and a critical step towards translating pancreas perfusion into clinical practice.”
Global Regulatory Agencies Provide Recommendation Guidance in Support of VitaSmart™
We are also encouraged by continued international institutional engagement surrounding machine perfusion technologies. The UK National Institute for Health and Care Excellence (NICE) just published guidance recommending the routine use of liver preservation machines within the National Health Service. Bridge to Life’s VitaSmart™ System was included among the technologies under evaluation. The inclusion of HOPE technologies within these discussions reflects growing recognition of machine perfusion as an increasingly important component of future transplant infrastructure and organ utilization strategies. The NICE HealthTech Guidance, titled “Ex-situ machine perfusion devices to preserve deceased donor livers for transplantation,” was published on August 20, 2026. You can read the published guidance here and following is a link to our press release.
Looking ahead, Bridge to Life remains committed to supporting clinical research, translational science, and broader adoption of advanced preservation technologies across abdominal organ transplantation.
VitaSmart™ Showcased at Global Transplantation Conferences
Scientific engagement and clinical research surrounding HOPE and mitochondrial preservation also continued throughout the spring congress season. At the 30th Annual Meeting of the Society of Pediatric Liver Transplantation (SPLIT), data presented demonstrated the feasibility and safety of HOPE in pediatric liver transplantation, including technically complex grafts and recipients.
The results of the study, “Hypothermic Oxygenated Machine Perfusion in the Use of Partial Grafts in Pediatric Liver Transplantation – Towards a New Standard of Care,” were presented by Karla Estefanía, MD, Department of Pediatric Surgery and Transplantation, Birmingham Children’s Hospital, Birmingham, UK, in the session on Oral Abstract Presentations and Travel Awards.
“Our study with 17 pediatric liver recipients (12 split, 5 reduced) adds to the growing evidence supporting the ability of HOPE to improve donor liver quality in pediatric liver transplantation,” commented Dr. Estefanía. “With death censored graft survival at 100%, no observed cases of primary non-function or early ischemic-type biliary lesions, and an estimated 27 percent reduction in cold ischemic times – critical for improving organ viability, graft function, and patient survival – HOPE can become a standard of care for partial graft utilization in pediatric liver transplantation.”
At the 2026 International Congress of the International Liver Transplantation Society (ILTS) in Geneva, Bridge to Life supported 12 scientific abstracts, including plenary and oral presentations exploring organ utilization, mitochondrial preservation, and translational research associated with hypothermic oxygenated perfusion. Several studies highlighted the growing role of HOPE in expanding the use of extended-criteria donor livers and supporting viability assessment strategies based on mitochondrial function. Visit our ILTS webpage to view a recording of our symposium or copies of our abstracts: ILTS congress 2026 Info Hub | Bridge to Life Ltd.
At the 2026 Annual Meeting of the American Transplant Congress (sponsored by the American Society of Transplantation and the American Society of Transplant Surgeons), new investigator-initiated research data demonstrated efficacy and safety of Bridge to Life’s VitaSmart™ Hypothermic Oxygenated Perfusion (HOPE) System in multiple organ transplants. Following is a link to our ATC landing page which features a recording of our symposium and copies of our abstracts: ATC 2026 | Bridge to Life Ltd.
Studies in human uterus and small intestine transplants, including head-to-head comparison with normothermic oxygenated perfusion, demonstrated that hypothermic oxygenated perfusion (HOPE) delivered using the VitaSmart™ System was feasible and was associated with favorable preservation parameters in human uterus and small intestine research grafts, further supporting the potential for HOPE to benefit multiple organs in future transplantation research. The FDA-cleared labeling for VitaSmart™ currently supports hypothermic oxygenated perfusion of donor livers prior to transplantation in both Donation after Brain Death (DBD) and Donation after Circulatory Death (DCD) donors, within defined donor criteria. The studies were presented orally, one during the Plenary Session.
“HOPE for Human Uterus Transplantation: Improved Preservation and Viability Assessment for Enhanced Donor Utilization,”
Keyue Sun, MD, Cleveland Clinic, et al
Cleveland Clinic study authors explained that uterus transplantation (UTx) is an emerging treatment for absolute uterine factor infertility. However, the use of deceased donors is limited, and DCD has not yet been utilized. Ischemic injury remains a major barrier, particularly compared with living donor procedures. HOPE, which has shown protective effects in heart, liver, and kidney transplantation, may offer similar benefits for uterine grafts.
Their observations are consistent with Cleveland Clinic experience from liver, kidney, and heart transplantation. In those organs, HOPE has been shown to reduce ischemia reperfusion injury and improve early graft function, especially in extended-criteria and DCD organs.
To their knowledge, study authors believe their study represents the first report describing HOPE in human deceased donor uteri and describes the associated metabolic and mitochondrial responses during perfusion. Researchers from Cleveland Clinic Foundation have been investigating mitochondrial metabolism during machine perfusion, using flavin mononucleotide (FMN) as a potential biomarker of organ viability and quality in transplantation.
Six uteri (3 DBD, 3 DCD) underwent eight hours of HOPE following procurement, while paired tissue controls were preserved using static cold storage (SCS). Perfusion was delivered using a pressure-controlled system. Perfusate and tissue samples were analyzed for mitochondrial injury, inflammation, and transcriptional responses. The uteri were perfused for ex situ research assessment and were not transplanted into recipients.
The study results showed that HOPE was associated with improved preservation by supporting mitochondrial metabolism and reducing biochemical markers of ischemic injury during perfusion, such as perfusate FMN. These findings provide initial human evidence that hypothermic oxygenated perfusion may serve as a preservation and metabolic assessment platform for deceased donor uterus grafts. Future studies incorporating reperfusion models, functional validation, and larger cohorts will be essential to determine whether machine perfusion can facilitate safer utilization of deceased donor uteri and support broader clinical application of uterus transplantation.
“Comparison of Hypothermic Oxygenated and Normothermic Machine Perfusion of Human Small Intestine for Transplantation,”
Koki Takase, MD, Cleveland Clinic, et al
Also at Cleveland Clinic, study authors explored the use of machine perfusion (MP) in the preservation of small intestine grafts prior to Intestinal transplantation (IT). To date, the authors state that intestinal transplant outcomes without machine perfusion face challenges due to high ischemia-reperfusion injury (IRI) and subsequent elevated immunogenicity of the grafts. MP techniques were shown to reduce IRI-related inflammation and improve outcomes in other solid organ transplantation, but its application for IT remains limited. This study compared the effects of HOPE and Normothermic Machine Perfusion (NMP) of human intestine to assess the condition after MP and identify the optimal approach for IT.
Twenty discarded intestines were included in this analysis (HOPE: 12, NMP: 8), and were perfused through HOPE, NMP after SCS. Perfusates and intestine tissue were assessed for mitochondrial injury, metabolic activity, IRI-associated inflammation, and epithelial injury.
The study found that perfusate FMN, a marker of mitochondrial injury, was significantly lower in the HOPE group than with NMP – indicating less mitochondrial damage during preservation. Perfusate release of mitochondrial complex I and II followed the same pattern, also significantly lower with HOPE.
Study authors concluded that end-ischemic (i.e., after SCS and before transplantation) HOPE of human intestine preserved the mitochondrial and metabolic function best compared to NMP. A pilot study is requested to proceed with the clinical application of HOPE for IT.
Use of VitaSmart™ System in uterus and intestine research described in these abstracts was investigational and is not included in the current FDA-cleared indications. Clinical application of HOPE in these organs would require additional studies and regulatory review.
Prestigious Peer-Reviewed Publications Support Broader Applications of VitaSmart™
Recent publications also point to applications of HOPE beyond abdominal organ preservation and ischemia-reperfusion management. Just published in the Journal of Clinical Medicine, “First Experience with Hypothermic Oxygenated Perfusion in Human Uteri: Feasibility and Metabolic Characterization,” out of Cleveland Clinic and Wake Forest Baptist for Fertility and Reproductive Surgery, explored the feasibility of hypothermic oxygenated perfusion in human uterine transplantation. Following is a link to the full publication: First Experience with Hypothermic Oxygenated Perfusion in Human Uteri: Feasibility and Metabolic Characterization – PubMed
Bridge to Life Research Blazes a Path Toward Biologically Guided, Viability-Informed Organ Assessment
Bridge to Life also continues to support research into mitochondrial biomarkers – most notably flavin mononucleotide (FMN) – and real-time viability assessment, areas that may further inform future decision-making in transplantation and organ acceptance.
FMN is a molecule released from mitochondrial complex I when a donor organ has sustained ischemic injury, and it can be measured directly in the perfusate during hypothermic oxygenated perfusion. Rather than inferring organ quality from donor characteristics, anatomy, or biopsy histology, FMN reports on the biology that actually determines how a graft will perform – the integrity of its mitochondria. The traditional tools used to judge a donor organ, including donor risk indices, biopsy, and measures such as lactate, pH, and transaminases, are largely indirect, static, or retrospective, and many lack validated thresholds for predicting clinically meaningful outcomes. They describe the organ; they do not measure its functional reserve in real time.
FMN, by contrast, can be quantified within the first 30 to 60 minutes of perfusion – before the transplant decision is made – giving the clinical team an objective, quantitative readout of mitochondrial injury at the moment it matters most. A growing international evidence base, including a multicenter validation study spanning ten centers across seven countries, has associated perfusate FMN with graft loss, early allograft dysfunction, and biliary complications. For the first time, the field has a real-time biomarker that aligns precisely with the mechanism HOPE is designed to address: the very mitochondrial injury that FMN measures is the injury that hypothermic oxygenated perfusion works to repair.
This is why Bridge to Life is investing here. Transplantation is moving – from preservation alone toward biologically guided, viability-informed organ assessment – and our intention is to skate to where the puck is going, not to where it is today. We believe the coming decade will be defined less by how organs are stored and more by how confidently their viability can be established before implantation. Our HOPE platform is built to sit at the center of that shift, and our continued research into FMN and related mitochondrial biomarkers is intended to place objective, real-time viability data directly in the hands of the teams making accept-or-decline decisions.
How this technology is adopted matters just as much as the technology itself. Bridge to Life does not simply install a system and step away. We partner with transplant programs to build durable HOPE capabilities – providing training, clinical and scientific support, research collaboration, and access to a growing body of shared evidence and benchmarking. Our goal is to help each center we work with develop into a true center of excellence in machine perfusion and viability-guided transplantation: a program positioned to safely expand its use of higher-risk and extended-criteria donor organs, to contribute to the science, and to deliver consistent outcomes for the patients who depend on it. While FMN is not part of the current VitaSmart™ cleared system, we share it here because we believe the transplant community deserves a clear view of where this field, and our commitment to it, is heading. As the evidence base matures, we look forward to continuing this conversation with the transplant community.
Kurt Cannon Joins Bridge to Life As Senior Vice President of Global Marketing
With VitaSmart™ commercialization well underway, Bridge to Life™ is excited to announce that Kurt Cannon, a MedTech industry veteran, has joined us as Senior Vice President of Global Marketing. Kurt brings nearly 25 years of MedTech commercial leadership experience to Bridge to Life™, with a background that spans marketing, sales, corporate accounts, operations, and general management. He has spent his career helping healthcare technology organizations turn strategy into execution, build strong commercial teams, and bring important products to market in highly specialized clinical environments.
Before joining Bridge to Life™, Kurt served as Vice President of Endoscopy Marketing at Olympus Corporation of the Americas, where he led marketing for a broad GI endoscopy capital and disposable portfolio and partnered closely across sales, clinical, strategy, regulatory, legal and commercial operations. Prior to Olympus, he held multiple leadership roles with Fujifilm Healthcare Americas and was part of the team that helped build and scale its U.S. GI endoscopy business in its early years. Kurt also brings five years of digital agency experience from Liquid Marketing, adding perspective in brand development, digital engagement, and customer-focused marketing execution.
Known as a culture-driven leader, Kurt believes growth is built through clear direction, strong teams, and disciplined execution. His approach is practical, collaborative, and grounded in staying close to customers while creating the conditions for people to do their best work. In his role at Bridge to Life™, Kurt is focused on advancing the company’s global marketing strategy, strengthening the overall brand, and helping lead the next stage of growth.
Moving Forward with Bridge to Life
But wait…there’s more!
Bridge to Life is looking forward to the The Transplantation Society (TTS) 2026 conference to be held in Sydney, Australia, September 20-23. Where we’ll be hosting a breakfast symposium on September 22. For more information please visit: https://bridgetolife.com/tts-2026/
Scaling Better Outcomes: The Role of HOPE in Contemporary Transplant Programs
Date/Time: September 22, 7:00 am – 8:00 am Location: Parkside 1 & 2
Moderator: Mauricio Carvalho, Bridge to Life
Session I: HOPE in Contemporary Clinical Practice: Workflow, Latest Data, and Outcome Trends
Speaker: Dr. Anji Wall, Baylor University Medical Center
Session II: Viability Assessment in HOPE Supported Transplantation: Viability Assessment: Current Approaches and Evolving Standards
Speaker: Dr. Andrea Schlegel, Cleveland Clinic
Session III: Extended Applications of HOPE: Beyond Standard Use: Pediatric, Living Donor, Surgical, Multivisceral, and Intestinal Applications
Speaker: Dr. Francisco Hernández Oliveros, Hospital Universitario La Paz (Madrid)
Keyue Sun, MD and Andrea Schlegel, MD from Cleveland Clinic, Ohio were selected to receive the TTS International Basic and Translational Science Mentee-Mentor Award 2026 recognizing the excellence of their abstract entitled “First Experience with Hypothermic Oxygenated Perfusion of Human Uteri: Feasibility and Metabolic Characterization,” previously presented at the American Transplant Congress in June.
For more information about the VitaSmart™ Hypothermic Oxygenated Perfusion System, Belzer UW® Cold Storage Solution, Belzer MPS® Machine Perfusion Solution, and other Bridge to Life products, please visit https://bridgetolife.com.
And do let us know if you have any questions or we can be of support in any way. We would not be at this stage of innovation without you, our valued partners, in this journey.
With our warmest regards,
Your Bridge to Life Team
